Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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Non-Clinical Supply Needs More Outsourcing Strength

A supply-chain reformer, book author, strategic advisor to drug sponsors of all sizes, investors, and policymakers, says, “The non-clinical supply chain as the foundation of reliable commercial supply receives too little attention from prospective clinical trial sponsors. We could be doing a heck of a lot better." A discussion between Hedley Rees and our Chief Editor, Louis Garguilo.

GUEST COLUMNISTS

Is Your Supply Chain Ready For The End Of Class VI?
Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.
Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs
Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system.
Why We Need Pharmaceutical Engineering Project Management As A Distinct Discipline
Applying general project management to a regulated setting as a variant of PMP or PRINCE2 is one of the most consistent, and most avoidable, causes of cost overrun and delayed start-up.
Complete Response Letters For CGTs Share This Common Theme
One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.
Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
The Orange Book's Blind Spot: Process Stability And Capability
The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.
Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

PHARMA OUTSOURCING WHITE PAPERS

Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

Drug Substance Development: Applying Platform Knowledge Across Modalities
Upstream processes often transfer readily, while downstream purification and formulation require product-specific adaptation and expert judgment.
Manufacturing Oncolytic Viruses: Where Complexity Demands Experience
Dose, concentration, potency, purity, recovery, and cost are closely linked in oncolytic virus manufacturing. Learn why early alignment can prevent costly challenges.
Integrating Drug Substance And Drug Product To Reduce Risk In Development
Discover how integrated planning, shared analytics, and greater continuity can support stronger decisions from early development through commercialization.
High-Throughput Binding Affinity Assessment Using Octet® HTX
Binding affinity screening of clones directly from crude supernatant, without purification, changes what can be assessed early, and a tiered workflow pairs broad throughput with deeper analytical characterization.
Turning Oncolytic Viruses Into Manufacturable Cancer Therapies
Oncolytic virus manufacturing depends on preserving infectivity and potency. Materials, hold times, and product-specific analytics shape scalability well before GMP production.